The health authorities in France and in Europe seem unable to distance themselves from pharmaceutical companies, and lack the courage to withdraw drugs with an unfavourable risk-benefit balance from the market.
For example, it has taken the European Committee for Medicinal Products for Human Use (CHMP) 5 years to suspend the marketing authorisation for efalizumab. And yet it was clear even before authorisation that the health damage caused by this antibody far outweighed its modest effect on psoriasis.
They seem to find it even harder to come to a decision concerning rosiglitazone. In 2002, it was already clear that this drug’s risk-benefit balance was unfavourable, but the European authorities approved it and allowed it to stay on the market. In 2008, the French committee that assesses the medical benefits of new drugs and provides recommendations on drug reimbursement (La Commission française de la transparence) studied the dossier anew. It noted the absence of therapeutic benefits and the extent of rosiglitazone’s adverse effects. But the Committee did not dare demand its withdrawal from the list of reimbursable drugs. It merely suggested a lower rate of reimbursement. Demonstrating further weakness, the decision finally taken by the French authorities was confined to a simple reduction in price.
Awareness of the damage suffered by victims of these harmful treatments is not enough to persuade the authorities to halt them. Anyone would think the authorities are so dependent on pharmaceutical companies that they are incapable of acting on their own.
©Prescrire 2009
Source: "Sevrage", Rev Prescrire 2009 ; 29 (306): 245.